Full-Time

Associate Director

Quantitative Pharmacology, Pharmacometrics

 Otsuka Pharmaceutical

Otsuka Pharmaceutical

1,001-5,000 employees

Global pharmaceutical company developing medicines

Compensation Overview

$169.2k - $253k/yr

+ Incentive Opportunity

Princeton, NJ, USA

Hybrid

Category
Biology & Biotech (1)
Required Skills
R
Julia
Requirements
  • In-depth knowledge of pharmacometrics, population pharmacokinetics and pharmacodynamics modeling, clinical pharmacology, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
  • Hands-on pharmacokinetic and pharmacokinetic/pharmacodynamic analysis and statistical analysis using Nonlinear Mixed Effects Modeling (NonMEM), Phoenix NLME, Julia, R.
  • Excellent working knowledge of phase I clinical operations, drug development, and multi-region regulatory requirements.
  • Good working knowledge of formulation development, drug development, and clinical development.
  • Current awareness of the latest developments in clinical pharmacology and related guidance documents.
  • PhD in pharmacometrics (or a related area such as pharmacokinetics, clinical pharmacology, pharmacology, or related fields) with a minimum of 5 years of experience in these areas and strong technical experience in population PK and PK/PD modeling.
  • Travel approximately 20%.
Responsibilities
  • Conduct pharmacometrics activities related to study design, protocol development, study execution, reporting and interpretation of data.
  • Conduct population pharmacokinetics, pharmacokinetics/pharmacodynamics and modeling and simulation.
  • Provide pharmacometrics analysis and participate in activities related to analysis and reporting of population pharmacokinetics and PK/PD analyses.
  • Authors pharmacometrics sections of clinical pharmacology documents for regulatory filings including annual reports, investigator’s brochure, IND/NDA applications and pediatrics development plans.
  • Work with bioanalytical team members on activities related to sample management, pharmacogenomics and biomarker development and provide analysis support related to PK and PK/PD.
  • Work with formulation development groups and provide support for PK/PK-PD activities related to formulation development, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations.
  • Manage pharmacometrics activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, statements of work and approval of invoices.
  • Interact with clinical pharmacology to support population PK and PK/PD modeling.
  • Serve as pharmacometrics lead on multiple project teams and as a team member on other key projects as needed and support model-based drug development strategies for ongoing projects.
Desired Qualifications
  • None
 Otsuka Pharmaceutical

Otsuka Pharmaceutical

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Otsuka Pharmaceutical is a global health-focused company that develops and markets medicines and nutraceutical products. It creates pharmaceuticals like Abilify (aripiprazole), an antipsychotic, and consumer health brands such as Pocari Sweat, an ion-replacement drink. Its products work by medical mechanisms (Abilify modulates dopamine and serotonin receptors to treat psychiatric conditions) and by supporting hydration and electrolyte balance (Pocari Sweat). Otsuka differentiates itself through a long, international growth path from its roots as a Japanese chemical manufacturer, a balanced portfolio spanning prescription drugs and health beverages, and a philosophy of developing new products to improve health worldwide. Its goal is to deliver healthier outcomes for people around the world by expanding access to innovative medicines and health-related consumer products.

Company Size

1,001-5,000

Company Stage

IPO

Headquarters

Tokyo, Japan

Founded

1921

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Simplify's Take

What believers are saying

  • Voyxact achieves 82.5% hematuria improvement in IgAN trial at 48 weeks.
  • Acquired Transcend Therapeutics for $700M to advance psychiatric MDMA analog.
  • Partnered Keio University on May 8, 2025, for psychedelics infrastructure.

What critics are saying

  • AbbVie acquires Gilgamesh bretisilocin for $1.2B, leapfrogging Otsuka psychedelics.
  • Voyxact confirmatory trial fails kidney preservation in 18-24 months.
  • Japanese regulations block psychedelics trials in 24-36 months.

What makes Otsuka Pharmaceutical unique

  • Pioneered IV solutions in 1946, becoming Japan's top supplier.
  • Launched Pocari Sweat ion drink and Abilify antipsychotic globally.
  • Focuses on carbostyril-based original drugs since 1980.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Company Match

Tuition Reimbursement

Student Loan Assistance

Paid Holidays

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Dealroom.co
Mar 27th, 2026
Transcend Therapeutics company information, funding & investors

Transcend Therapeutics, developing the next generation of psychoactive compounds for neuropsychiatry focused on patient access. Here you'll find information about their funding, investors and team.

Fierce Biotech
Mar 27th, 2026
Otsuka buys Transcend Therapeutics for $700M upfront in psychiatric drugs deal

Otsuka Pharmaceutical has acquired Transcend Therapeutics for $700 million upfront through its subsidiary Otsuka America, with potential milestone payments of up to $525 million. The deal gives Otsuka access to Transcend's MDMA analogue for psychiatric conditions currently in development.

The Associated Press
Mar 25th, 2026
Otsuka's Voyxact shows 82.5% hematuria improvement in IgA nephropathy trial at 48 weeks

Otsuka presented new Phase 3 VISIONARY trial data for VOYXACT (sibeprenlimab-szsi) in IgA nephropathy patients at the 2026 ISN World Congress of Nephrology. The analyses showed 82.5% of patients receiving sibeprenlimab achieved negative microscopic hematuria at week 48, compared with 52.6% on placebo. Median time to achieve hematuria negativity was nine weeks versus 24 weeks for placebo. VOYXACT, approved under accelerated approval in the US, is a monoclonal antibody that inhibits APRIL, a key driver in IgAN pathogenesis. Previously reported data showed the drug met its primary endpoint with a 51.2% placebo-adjusted reduction in proteinuria at nine months. The trial continues evaluating sibeprenlimab's effect on preserving kidney function over 24 months.

Business Wire
Mar 2nd, 2026
Paradise ultrasound renal denervation system now covered by insurance in Japan for resistant hypertension

Otsuka Medical Devices and Otsuka Pharmaceutical have launched the Paradise Ultrasound Renal Denervation system in Japan, with National Health Insurance coverage effective 1 March. The device, developed by US subsidiary Recor Medical, treats resistant hypertension by reducing sympathetic nerve overactivity surrounding renal arteries. The system targets patients whose blood pressure remains above target despite using three different antihypertensive medications, including a diuretic. This marks Japan's first ultrasound renal denervation treatment. The Paradise system received FDA approval in the US in November 2023. Under a co-promotion agreement, both Otsuka companies will leverage their cardiovascular and renal expertise to deliver the treatment according to guidelines established by Japanese medical societies. The system offers a new option for resistant hypertension patients at high risk of serious cardiovascular complications.

The Associated Press
Feb 6th, 2026
Sky Labs secures exclusive deal with Otsuka Pharmaceutical to launch ring-type blood pressure monitor in Japan

Sky Labs has signed an exclusive distribution agreement with Otsuka Pharmaceutical to launch its ring-type blood pressure monitor, CART BP pro, in Japan's hospital and clinic market. The deal follows an MoU signed in December 2024. CART BP pro uses photoplethysmography technology to measure blood pressure without a cuff, allowing comfortable monitoring during daily activities and sleep. The device has already achieved success in South Korea, with over 150,000 prescriptions across 1,700 medical institutions since its 2023 approval and national health insurance coverage in 2024. Japan's hypertension market includes approximately 43 million patients, with 29% failing to achieve blood pressure control and 33% unaware of their condition. Sky Labs will leverage Otsuka's distribution network and cardiovascular expertise to expand across Japanese healthcare facilities.